An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
Overview
- Phase
- Phase 1
- Intervention
- LY2127399
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
30mg/120 mg LY2127399
Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.
Intervention: LY2127399
120 mg LY2127399
Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.
Intervention: LY2127399
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 72 weeks
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
Secondary Outcomes
- Percent Change From Baseline in CD20+ B-cell Count(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Peripheral B-cell Subsets(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA](Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Rheumatoid Factor (RF)(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in C-Reactive Protein (CRP)(Baseline and Weeks 12, 24, 36, 52, and 72)
- Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline and Weeks 12, 24, 36, 52, and 72)